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Barostim神经激素干预改善心力衰竭治疗 (BENEFIT-HF)

2026年11月6日 更新者：CVRx, Inc.

Barostim 增强神经激素干预改善心力衰竭治疗 (BENEFIT-HF)

The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF < 50% and NT-proBNP < 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

2500

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Alabama
      • Mobile、Alabama、美国、36608
        • 招聘中
        • Cardiology Associates of Mobile
        • 接触：
        • 首席研究员：
          • Kenneth Burnham, MD
    • California
      • Los Angeles、California、美国、90033
        • 招聘中
        • Keck School of Medicine of USC
        • 首席研究员：
          • Michael Fong, MD
        • 接触：
      • Los Angeles、California、美国、90017
        • 招聘中
        • PIH Health Good Samaritan Hospital
        • 接触：
        • 首席研究员：
          • Joseph Rahman, MD
    • Florida
      • Clearwater、Florida、美国、33756
        • 招聘中
        • BayCare Health System
        • 首席研究员：
          • Leslie Miller, MD
        • 接触：
      • Jacksonville、Florida、美国、32256
        • 招聘中
        • First Coast Cardiovascular Institute
        • 接触：
        • 首席研究员：
          • Sumant Lamba, MD
      • Orlando、Florida、美国、32803
        • 招聘中
        • AdventHealth Orlando
        • 首席研究员：
          • Stacy Mandras, MD
        • 接触：
      • Tallahassee、Florida、美国、32308
        • 招聘中
        • Tallahassee Research Institute
        • 接触：
        • 首席研究员：
          • Gian-Carlo Giove, MD
      • Tampa、Florida、美国、33606
        • 招聘中
        • Tampa General Hospital
        • 接触：
      • Tampa、Florida、美国、33614
        • 招聘中
        • BayCare Health Systems
        • 首席研究员：
          • Laurie Letarte, MD
        • 接触：
    • Illinois
      • Elk Grove Village、Illinois、美国、60007
        • 招聘中
        • Ascension Alexian Brothers
        • 首席研究员：
          • Ashish Haryani, MD
        • 接触：
      • Moline、Illinois、美国、61265
        • 招聘中
        • Cardiovascular Medicine
        • 首席研究员：
          • Mark Shen, MD
        • 接触：
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • 招聘中
        • Ascension St. Vincent
        • 首席研究员：
          • Ashwin Ravichandran, MD
        • 接触：
    • Massachusetts
      • Boston、Massachusetts、美国、02111
        • 招聘中
        • Tufts Medical Center
        • 接触：
        • 首席研究员：
          • Michael S. Kiernan, MD
    • Missouri
      • Kansas City、Missouri、美国、64111
        • 尚未招聘
        • Saint Luke's Hospital of Kansas City
        • 首席研究员：
          • Timothy Fendler, MD
        • 接触：
    • Nebraska
      • Omaha、Nebraska、美国、68198
        • 招聘中
        • University of Nebraska Medical Center
        • 接触：
    • New York
      • New York、New York、美国、10032
        • 尚未招聘
        • Columbia University Medical Center/NewYork Presbyterian Hospital
        • 首席研究员：
          • Gabriel Sayer, MD
        • 接触：
    • Ohio
      • Cincinnati、Ohio、美国、45219
    • Oklahoma
      • Tulsa、Oklahoma、美国、74136
        • 尚未招聘
        • Saint Francis Hospital
        • 首席研究员：
          • Douglas Ensley, MD
        • 接触：
    • South Dakota
      • Sioux Falls、South Dakota、美国、57108
        • 招聘中
        • North Central Heart
        • 首席研究员：
          • Orvar Jonsson, MD
        • 接触：
    • Tennessee
      • Chattanooga、Tennessee、美国、37403
        • 招聘中
        • Erlanger Health
        • 接触：
        • 首席研究员：
          • Patrick Stevens, MD
      • Germantown、Tennessee、美国、38138
        • 招聘中
        • Stern Cardiovascular Center
        • 首席研究员：
          • Frank McGrew, MD
        • 接触：
    • Texas
      • Tyler、Texas、美国、75701
    • Wisconsin
      • Marshfield、Wisconsin、美国、54449

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age 18 years or above

  2. NYHA Functional Class II or III heart failure symptoms at the time of screening

  3. Left ventricular ejection fraction < 50% within 6 months of consent

  4. Heart failure accompanied by either:

    • Screening local lab NT-proBNP ≥ 400 AND < 5,000 pg/mL or a BNP ≥100 AND < 1,250 pg/mL, adjusted for BMI in a stable outpatient setting OR
    • A documented Worsening Heart Failure Event in the 6 months prior to or concurrent with consent, AND an NT-proBNP < 5,000 pg/mL or BNP < 1,250 pg/mL, adjusted for BMI in a stable outpatient setting.

    Note: If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility. NT-proBNP and BNP to be adjusted for BMI using a 4% reduction per BMI unit over 25 kg/m2.

  5. On optimal, maximally tolerated Guideline Directed Medical Therapy (GDMT) (medications and devices) per current country specific guidelines (e.g. US follows AHA/ACC guidelines, Germany follows DGK/ESC guidelines) for the treatment of heart failure, when appropriate, throughout screening/baseline evaluation and for at least 4 weeks prior to consent:

    • No more than a 100% increase or a 50% decrease of the dosage of any one medication other than an oral diuretic.
    • Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above.
    • Unrestricted changes in oral diuretics are allowed.
    • For participants with LVEF between 40-50%, SGLT2 inhibitors and mineralocorticoid receptor antagonists (MRAs) are encouraged and should be initiated before consent when possible.

  6. Six-minute hall walk (6MHW) ≥ 100 m AND ≤ 450 m within 15 days after consent.

  7. If female and of childbearing potential, must have a negative pregnancy test within 15 days after consent.

  8. Be an appropriate candidate for the trial and the surgical procedure as determined by the investigator or designee and the surgeon.

  9. Have signed an informed consent form for participation in this trial.

Exclusion Criteria:

  1. Any contraindications to Barostim as noted in Instructions for Use.

  2. An existing device which contraindicates Barostim specifically or unipolar therapy in general.

  3. Advanced heart failure defined by any of the following:

    • AHA/ACC Stage D heart failure.
    • Two or more NT-proBNP results >5,000 pg/mL or BNP >1,250 pg/mL in a stable outpatient setting within 3 months prior to consent. If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility.
    • Current or prior continuous or intermittent intravenous positive inotrope therapy.
    • Has received, is receiving, or scheduled to receive LVAD therapy.
    • Solid organ or hematologic transplant or currently being evaluated for cardiac transplant.

  4. Serum estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 or has end-stage renal disease.

  5. Recurring symptomatic hypotension.

  6. Life expectancy less than one year.

  7. An inappropriate trial candidate as evidenced by at least one of the following:

    • Has received or is receiving chronic dialysis.
    • Is within WHO groups 1, 3, 4, or 5 pulmonary hypertension.
    • Severe COPD or severe restrictive lung disease requiring chronic oral steroid use or any oxygen use.
    • Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.
    • Active malignancy with the exception of non-melanoma skin cancers.
    • Infiltrative cardiomyopathy (e.g. cardiac amyloidosis).
    • Any other serious medical condition that may adversely affect the safety of the participant or validity of the trial, in the opinion of the investigator.

  8. Any of the following within 3 months prior to consent:

    • Myocardial infarction
    • Unstable angina
    • Percutaneous coronary intervention (e.g. PTCA)
    • Cerebral vascular accident or transient ischemic attack
    • Cardiac arrest
    • Surgical cardiac intervention (e.g., CABG, cardiac ablation, valve replacement, CRT/ICD implantation, IPG battery replacements)

  9. Surgery planned to occur within 45 days of the Barostim implant procedure. This includes pacemaker or ICD implants or battery replacements.

  10. Enrolled and active in another clinical trial (e.g. device, pharmaceutical, or biological) unless approved by the CVRx Clinical Research department.

  11. Unable or unwilling to fulfill the Protocol medication compliance and follow-up requirements, for reasons including but not limited to an unresolved history of alcohol or substance abuse or psychiatric disorder. Participant is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also include university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Device Arm

Participants will receive Baroreflex Activation Therapy (BAT) with an implanted Barostim System in addition to usual care medical management.
设备：Barostim System

Baroreflex Activation Therapy (BAT) using the Barostim System
有源比较器：Control Arm

Participants will receive usual care medical management alone with no Barostim System device implant.
其他：Usual care medical management

Usual care medical management alone - no device implant

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Primary Effectiveness Endpoint
大体时间：Through 24-months follow-up

Composite of all-cause mortality and Heart Failure Morbidity, defined as Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events, assessed through 24 months of follow-up.
Through 24-months follow-up
Primary Safety Endpoint
大体时间：Within 180 days of the device implant

The event-free rate of all system- and procedure-related Major Adverse Neurological and Cardiovascular Events (MANCE) occurring within 180 days of the device implant, assessed among participants who were randomized to the Device Arm and in whom an implant has been achieved or attempted.
Within 180 days of the device implant

次要结果测量

结果测量
措施说明
大体时间
因死亡或住院损失的天数
大体时间：24个月随访
24个月随访
Quality of Life (QoL) Score Change
大体时间：12-months follow-up

QoL score change from baseline to 12 months, measured by the Minnesota Living With Heart Failure (MLWHF) questionnaire, a 21-question survey that uses a 0-5 scale where a lower score indicates better QoL.
12-months follow-up
6MHW distance change
大体时间：12-months follow-up

6-minute hall walk (6MHW) distance change from baseline to 12 months.
12-months follow-up
NT-proBNP level change
大体时间：12-months follow up

NT-proBNP level change from baseline to 12 months
12-months follow up
All-cause mortality
大体时间：24-months follow-up

All-cause mortality rate for all randomized participants through 24-months of follow-up.
24-months follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

CVRx, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月24日

初级完成 (估计的)

2033年1月1日

研究完成 (估计的)

2033年1月1日

研究注册日期

首次提交

2025年11月14日

首先提交符合 QC 标准的

2025年11月14日

首次发布 (实际的)

2025年11月18日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 360069-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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